Nostrum Pharmaceuticals, LLC v. United States Food and Drug Administration

Plaintiff Nostrum Pharmaceuticals, LLC ("Nostrum" or "Plaintiff") brings this action challenging certain decisions of the United States Food and Drug Administration ("FDA" or "Defendant") relating to Nostrum's Abbreviated New Drug Application ("ANDA") for carbamazepine 300 mg extended-release capsules. Nostrum alleges that the FDA incorrectly determined that Nostrum's statutory exclusivity period for marketing its generic carbamazepine product has expired as to U.S. Patent No. 5,912,013 ("the '013 patent") and may be shortened as to U.S. Patent 5,326,570 ("the '570 patent") by reason of pending expiration of that patent. Apotex Inc. ("Apotex"), a subsequent ANDA filer for carbamazepine extended-release capsules, has intervened in the matter as a defendant. Presently before the Court is a motion by Nostrum for a preliminary injunction enjoining the FDA from approving any competing carbamazepine ANDAs until after November 16, 2011, on which date Nostrum will have had the full statutory 180 days of marketing exclusivity. Alternatively, Nostrum seeks an order enjoining the FDA from approving competing ANDAs without advance notice to both Nostrum and the Court sufficient to permit Nostrum to move the court for relief to protect its exclusivity. The FDA and Apotex have filed opposition the motion. The Court heard oral argument on the motion June 27, 2011, and Plaintiff has requested the Court issue an expedited decision in light of the time-sensitive nature of the issues in order to allow it to take a prompt appeal. For the reasons below, Nostrum's motion is denied.

I. Background

A. Generic Drug Approval Process

Under the Federal Food, Drug, and Cosmetic Act ("FDCA"), the FDA is authorized to regulate the manufacture, distribution, and sale of drugs in the United States. In accordance with the FDCA, pharmaceutical companies seeking to market new drugs (often referred to as "pioneer" or "branded" drugs) must first obtain FDA approval by filing a new drug application ("NDA") containing extensive scientific data demonstrating the safety and effectiveness of the drug. U.S.C. §§ 355(a), (b). An NDA applicant must also submit information on any patent that claims the drug, or a method of using the drug, and for which a claim of patent infringement could reasonably be asserted against an unauthorized party. 21 U.S.C. §§ 355(b)(1), (c)(2). The FDA publishes this patent information in the "Approved Drug Products with Therapeutic Equivalence Evaluations" list, commonly known as the "Orange Book." Id.; see also 21 C.F.R. § 314.53(e).

The approval of generic drugs is governed by the FDCA as modified by the Drug Price Competition and Patent Term Restoration Act of 1984 (the "Hatch-Waxman Amendments"), codified at 21 U.S.C. § 355 and 35 U.S.C. §§ 156, 271, and 282. These amendments were designed to balance the interests of encouraging innovation in the development of new drugs and accelerating the availability of lower-cost generic alternatives to branded drugs.

Under the Hatch-Waxman Amendments, a manufacturer submits an abbreviated new drug application ("ANDA") requesting approval of a generic version of an approved drug product. 21 U.S.C. § 355(j). The ANDA must include, among other things, data showing that the generic drug product is the bioequivalent to the branded drug product. 21 U.S.C. § § 355(j)(2)(A)(iv); (j)(4)(F). With respect to Orange Book listed patents for the branded drug, an ANDA must contain one of four certifications:

(I) that such patent information has not been filed,

(II) that such patent has expired,

(III) .the date on which such patent will expire, or

(IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted.

An applicant wishing to challenge the validity of a patent or to claim that the patent would not be infringed by the product covered by the ANDA submits a paragraph IV certification. The filing of a paragraph IV is an act of infringement, 35 U.S.C. § 271(e)(2)(A), and if a suit is brought within 45 days of receipt of notice of the certification by the patent owner or NDA applicant, the FDA must stay approval of the ANDA for up to 30 months. 21 U.S.C. § 355(J)(5)(B)(iii). If no action is brought within the requisite period, the FDA may approve the ANDA immediately. 21 U.S.C. § 355(J)(5)(B)(iii).

To encourage generic drug companies to bear the costs and potential
risks associated with submitting a paragraph IV certification, the
Hatch-Waxman Amendments provide a "180-day exclusivity period" to the
applicant who is the first to file an ANDA containing a paragraph IV
certification. 21 U.S.C. § 355(j)(5)(B)(iv). During this period, the
applicant who is the first to file may market its product while FDA
approval of all other ANDAs covering the same product are delayed.
Under the statutory provisions relevant to this action,*fn1
the 180 period begins to run the earlier of (1) the first
commercial marketing of the generic drug by the first ANDA filer; or
(2) "the date of a decision of a court . holding the patent which is
the subject of the certification to be invalid or not infringed."

21 U.S.C. § 355(j)(5)(B)(iv) (2002). B. Nostrum's ANDA

The relevant facts in this matter are undisputed. Shire Development Inc. ("Shire")

is the reference listed drug manufacturer for carbamazepine extended-release capsules, marketed under the brand name Carbatrol. Two patents are listed in the Orange Book for Carbatrol: the '013 patent and the '570 patent.

On March 26, 2003, Nostrum was the first to file an ANDA for the 300 mg strength of carbamazepine containing paragraph IV certifications as to the '013 and '570 patents. On September 18, 2003, Shire commenced patent infringement litigation against Nostrum. Shire Labs. v. Nostrum Pharms. Inc., Civil Action No. 03-4436-MLC (D.N.J.). In 2006, the matter was stayed and, thereafter, the stay was extended a number of times. On March 22, 2010, the parties ultimately settled. This settlement included a license giving Nostrum the right to sell carbamazepine extended release capsules on or after October 1, 2010. According to Nostrum, it was prepared to market its generic product as of that date; however, its release was subject to FDA approval, which had not yet been granted.

Nostrum's ANDA received final FDA approval on May 20, 2011. In its approval letter, the FDA recognized that Nostrum was the first to file an ANDA for carbamazepine containing a paragraph IV certification as to the '013 and '570 patents and, therefore, was eligible for the 180-day exclusivity period. Mulye Decl. Ex. A at 2. However, the FDA determined that such exclusivity would be based only upon the '570 patent because, as the FDA advised Nostrum, it concluded that the exclusivity period for the '013 patent had been triggered by a 2009 judgment in the matter Shire Labs, Inc. v. CorePharma, LLC, Civil Action 06-2266 (D.N.J.). Id. Shire was a patent infringement action in which the court had granted a motion for summary judgment and entered final judgment in favor of defendant CorePharma LLC on July 14, 2009. Thus, according to the FDA, upon approval of Nostrum's ANDA, the exclusivity period for the '013 patent had long since expired.

Nostrum began marketing its product immediately upon approval and, as such, there is no dispute that the start of the exclusivity period as to the '570 was triggered on that date. The '570 patent expires on July 23, 2011.*fn2 See Notice at D.I. 30. It is the FDA's position that, for reasons described more fully below, upon expiration of the '570 patent any ...

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